Cleared Traditional

K801002 - OTICON EARETTE HEARING AID #E17 HC

K801002 is an FDA 510(k) clearance for OTICON EARETTE HEARING AID #E17 HC, manufactured by Oticon Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801002 · Oticon Corp. · Ear, Nose, Throat device
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May 1980
Decision
30d
Days
Class 1
Risk

K801002 is an FDA 510(k) clearance for the OTICON EARETTE HEARING AID #E17 HC. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oticon Corp. devices

FDA 510(k) Submission Details - K801002

510(k) Number K801002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date May 28, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K801002.
OTICON MODEL E17P EARETTE HEARING AID
K801448 · Oticon Corp. · Jul 1980
HEARING AID, UNITRON MODEL C4-55
K801230 · Unitron Industries, Inc. · Jun 1980
BEHIND-THE-EAR HEARING AID SERIES G
K801062 · Maico Hearing Instruments, Inc. · Jun 1980
OTICON EARETTE HEARING AID #E17CF
K801003 · Oticon Corp. · May 1980
DAHLBERG HEARING AID MODEL MEH
K801114 · Dahlberg Electronics, Inc. · May 1980
DAHLBERG HEARING AID MODEL MEL
K801115 · Dahlberg Electronics, Inc. · May 1980